Investigation of the Effect of Erector Spinae Plane Block on Systemic Immuno-Inflammatory Index

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-15

Study Completion Date

2023-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Erector spinae plane block (ESPB) is a novel interfascial block technique first described by Forero in 2016. It has been reported to be effective in various clinical indications. In ESPB, local anesthetic is injected between the deep fascia of the erector spinae muscle and the transverse process of the vertebra, allowing cephalocaudal spread along the erector spinae muscle. The goal of the injection is to provide sensory blockade by affecting the anterior rami of the spinal nerves in the region.

ESPB has been used during breast and axillary lymph node surgeries to manage postoperative pain. In addition to tumor cells, immune and inflammatory cells such as neutrophils, platelets, and lymphocytes contribute to the dissemination and invasion of tumor cells into the peripheral circulation. Noninvasive biomarkers such as serum inflammatory markers are increasingly valued for their simplicity and predictive potential. Platelets have been shown to facilitate epithelial-mesenchymal transition of tumor cells; neutrophils support tumor adhesion via growth factors such as VEGF and proteases; lymphocytes play a role in modulating the host immune response to malignancy.

The systemic immune-inflammatory index (SII), calculated as (platelet count × neutrophil count) / lymphocyte count, is a relatively new composite marker that reflects immune and inflammatory responses. It has been evaluated as a prognostic biomarker in several cancer-related studies.

Postoperative pain and surgical stress activate systemic inflammatory responses. ESPB is performed as part of postoperative analgesia in patients undergoing breast cancer surgery under general anesthesia, based on voluntary participation. The aim of this study is to evaluate the effect of ESPB on postoperative SII levels in comparison to other analgesia modalities.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Analgesic Efficacy of Erector Spinae Plane Block After Breast Cancer Surgery

NCT04512391

Postoperative Pain Breast Cancer

COMPLETED

Different Volumes of Erector Spinae Plane Block for Breast Surgery

NCT05232084

Breast Cancer Breast Neoplasms Breast Diseases

COMPLETED NA

The Effects of Erector Spinae Plane Block on Pain Scores in Unilateral Breast Cancer Surgery

NCT07134933

Erector Spinae Plane Block

COMPLETED NA

Erector Spinae Block in Segmental Mastectomy.

NCT03509090

Breast Cancer

UNKNOWN NA

Impact of Erector Spinae Plane Block on Systemic Immune-inflammation Index

NCT07137702

Systemic Immune-inflammatory Index Erector Spinae Plane Block Breast Conserving Surgery

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Erector Spinae Plane Block Systemic Immune-inflammatory Index Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Erector spinae plane block

Preoperative thoracic level 4 ESP block was applied

Group Type EXPERIMENTAL

Erector spinae plane block

Intervention Type PROCEDURE

This study aims to compare the effects of erector spinae plane block (ESPB) and systemic tramadol use as postoperative analgesia methods on the systemic immune-inflammatory index (SII) in patients undergoing breast cancer surgery.

Control

Group with analgesia provided by Contromal (IM) without blockade

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Erector spinae plane block

This study aims to compare the effects of erector spinae plane block (ESPB) and systemic tramadol use as postoperative analgesia methods on the systemic immune-inflammatory index (SII) in patients undergoing breast cancer surgery.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Female patients aged 18-75 years
* ASA (American Society of Anesthesiologists) physical status I-II-III
* Undergoing unilateral breast cancer surgery under general anesthesia
* Volunteered to participate in the study and signed informed consent

Exclusion Criteria

* Allergy or contraindication to local anesthetics
* Coagulopathy or on anticoagulant therapy
* Infection at the injection site
* History of chronic pain or opioid use
* Neurological or psychiatric disorders affecting pain perception
* Refusal to receive regional anesthesia

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No